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AS/NZS 4659.

3:1999
(Incorporating Amendment No. 1)

AS/NZS 4659.3

Australian/New Zealand Standard


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Guide to determining the equivalence of food microbiology test methods Part 3: Confirmation tests

AS/NZS 4659.3:1999 This Joint Australian/New Zealand Standard was prepared by Joint Technical Committee FT/4, Food Microbiology. It was approved on behalf of the Council of Standards Australia on 12 November 1999 and on behalf of the Council of Standards New Zealand on 8 December 1999. It was published on 5 December 1999.

The following interests are represented on Committee FT/4: Australia New Zealand Food Authority Australian Chamber of Commerce and Industry Australian Food and Grocery Council Australian Government Analytical Laboratories Australian Industry Group Australian Institute of Food Science and Technology Australian Poultry Industries Association Commonwealth Scientific and Industrial Research Organization Department of Defence (Australia) Department of Agriculture, Fisheries and Forestry (Commonwealth) Department of Primary Industries Queensland Environmental Science and Research, New Zealand Food Science Australia Food Technology Association of Victoria National Association of Testing Authorities Australia NSW Dairy Corporation NSW Health Department Queensland Health RMIT University The University of Melbourne The University of Queensland The Western Australian Centre for Pathology & Medical Research Additional interests participating in preparation of Standard: Dairy Industry Quality Centre

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Keeping Standards up-to-date Standards are living documents which reflect progress in science, technology and systems. To maintain their currency, all Standards are periodically reviewed, and new editions are published. Between editions, amendments may be issued. Standards may also be withdrawn. It is important that readers assure themselves they are using a current Standard, which should include any amendments which may have been published since the Standard was purchased. Detailed information about joint Australian/New Zealand Standards can be found by visiting the Standards Australia web site at www.standards.com.au or Standards New Zealand web site at www.standards.co.nz and looking up the relevant Standard in the on-line catalogue. Alternatively, both organizations publish an annual printed Catalogue with full details of all current Standards. For more frequent listings or notification of revisions, amendments and withdrawals, Standards Australia and Standards New Zealand offer a number of update options. For information about these services, users should contact their respective national Standards organization. We also welcome suggestions for improvement in our Standards, and especially encourage readers to notify us immediately of any apparent inaccuracies or ambiguities. Please address your comments to the Chief Executive of either Standards Australia International or Standards New Zealand at the address shown on the back cover.

This Standard was issued in draft form for comment as DR 98541.

AS/NZS 4659.3:1999
(Incorporating Amendment No. 1)

Australian/New Zealand Standard


This is a free 6 page sample. Access the full version at http://infostore.saiglobal.com.

Guide to determining the equivalence of food microbiology test methods Part 3: Confirmation tests

First published as AS/NZS 4659.3:1999. Reissued incorporating Amendment No. 1 (February 2002).

COPYRIGHT
Standards Australia/Standards New Zealand All rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher. Jointly published by Standards Australia International Ltd, GPO Box 5420, Sydney, NSW 2001 and Standards New Zealand, Private Bag 2439, Wellington 6020
ISBN 0 7337 3060 4

AS/NZS 4659.3:1999

PREFACE
This Standard was prepared by the Joint Standards Australia/Standards New Zealand Committee FT/4, Food Microbiology. This Standard incorporates Amendment No. 1 (February 2002). The changes required by the Amendment are indicated in the text by a marginal bar and amendment number against the clause, note, table, figure or part thereof affected. The objective of this Standard is to provide guidance on determining the equivalence of microbiological test methods. This Part covers how to determine whether an alternate method will yield a result equivalent to an Australian Standard or to a Joint Australian/New Zealand Standard, for confirmation tests using a pure culture.
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It is not intended that this Standard be applied retrospectively to existing laboratory validation studies, nor that it replace the validation of methods such as performed under the auspices of the Association of official Analytical Chemists, International or the Micro Val project of the European Union, which usually aim to validate a method which is applicable to a number of foods and applicable under a variety of laboratory conditions. This guide to validation is intended for individual laboratories wishing to validate procedures that are alternatives to Standard methods. It allows the validation to be performed in a single laboratory. The result of following the procedures in this Guide is the production of a report which will in some specific situations allow a laboratory and its clients to determine or agree on whether an alternative method is suitable as a substitute for a Standard method. The results may then be applied to other laboratories. This Standard is one of a series of Guides covering determination of the equivalence of food microbiology test methods. The other three Parts cover qualitative tests, quantitative tests and antibiotic tests.

CONTENTS
Page FOREWORD ............................................................................................................................. 3 1 2 3 4 5 SCOPE ................................................................................................................................ 4 REFERENCED DOCUMENTS .......................................................................................... 4 DEFINITIONS .................................................................................................................... 4 PROCEDURE ..................................................................................................................... 5 REPORT ............................................................................................................................. 8

AS/NZS 4659.3:1999

FOREWORD
An alternate method will be considered to be validated if it is shown to yield results that are equivalent to those of the Australian or Australian/New Zealand Standard method and a sensitivity equivalent to the Australian or Australian/New Zealand Standard method. The method is being validated for the matrix employed, not the laboratory or staff where the validation was performed. This means that a method validated for a particular matrix can be adopted by other laboratories on the basis of the validation report. The alternate method may prove to be superior to the reference method for a number of reasons, even though it may not be validated according to the criteria in this Guide. In this case, as with any validation study, it is the right of any laboratory and its client to choose a method based on all the available information.
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Reference cultures need to be used when performing an alternate method as specified in the relevant part of AS 1766 or AS/NZS 1766, even after validation of the alternate method according to this Guide. A minimum of twenty isolates of the target organism and thirty isolates of negative control organisms are also to be tested by the alternate method and the Australian or Australian/New Zealand Standard method. The number of positive results are recorded and statistical analysis performed. An equivalent number of negative control organisms are also tested. If the particular test requires a purification and/or isolation step, then it is essential that it be included.

AS/NZS 4659.3:1999

STANDARDS AUSTRALIA/STANDARDS NEW ZEALAND Australian/New Zealand Standard Guide to determining the equivalence of food microbiology test methods Part 3: Confirmation tests
1 SCOPE The protocol outlined in this Standard may be used to determine whether an alternate method will yield a result equivalent to an Australian or Australian/New Zealand Standard, food microbiology method (AS 1766/AS/NZS 1766 series Standards), for confirmation tests using a pure culture. As we are dealing with pure cultures, the matrix will have no bearing on the validation of a particular test kit. 2 REFERENCED DOCUMENTS The following documents are referred to in this Standard: AS or AS/NZS 1766

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Food microbiology (series)

3 DEFINITIONS For the purpose of this Standard the definitions below apply: 3.1 Alternate method The method which is to be validated. 3.2 False negative The alternate method yields a negative result but the reference method yields a positive result. 3.3 False positive The alternate method yields a positive result but the reference method yields a negative result.
NOTE: A 'false positive' may be a true positive which was not detected by the reference method. Such occurrences need to be carefully verified. For the purpose of this Guide they will be considered false positives because the guide is aimed at demonstrating the equivalence of the two methods.

3.4 Reference method The Australian or Australian/New Zealand Standard method against which the alternate method will be compared. 3.5 Target organism The genus, species, antigenically, toxicologically or physiologically defined group of organisms which the reference method is designed to detect.

COPYRIGHT

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AS/NZS 4659.3:1999, Guide to determining the equivalence of food microbiology test methods Confirmation tests

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